Shoulder Pain
Conditions
Brief summary
Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids. The specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. This is a 'before and after' study. We plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. Both groups will receive identical postoperative follow-up.
Detailed description
Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as inpatient and patients had availability of intravenous opioids. Assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, SD 2.1 (Kahn) which is often categorized as severe pain. Given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. With outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. Therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. Given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. This study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.
Interventions
OTHERPathway
The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components. Both groups will receive identical postoperative follow-up.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory rotator cuff patients with participating surgeons. Includes the following concomitant procedures: * Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair * Arthroscopic Stabilization * Arthroscopic AC (Acromioclavicular) resection * Arthroscopic SAD (Sub-Acromial Decompression) * Arthroscopic or mini open biceps tenodesis * Age 18-80
Exclusion criteria
* chronic pain history (defined as use of opioids \> 3 months or current gabapentinoids for pain) * open surgery (but sub pectoralis mini open biceps tenodesis is not excluded) * revision surgery * kidney disease (GFR \< 60 ml/min/1.73 m2 for 3 months or more) * liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy) * planned avoidance of regional anesthesia * any contraindication to or patient refusal of any component in the pathway * Non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome - Worst NRS With Movement | 0-48 hours after block placement | worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Use | Post Op Days 1,2,7,14 | The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated. |
| Patient Satisfaction With Pain Management | Post Op Days 1,2,7,14 | Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome. |
| Pain Score at Rest | Post Op Days 1,2,7,14 | a NRS score on a scale from 0 to 10. 0 means no pain and 10 is the worst pain imaginable. A lower score is a better outcome. |
| Block Duration | Through Post Op Day 2 | Measures the duration of the block from: the time the block started to the time the block completely wore off the time the block started to the time the patient first noticed pain the time the block started to the time the patient felt normal sensation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Before Group We plan to have 70 patients studied prior to initiation of a pathway. | 70 |
| After Group We plan to have 70 patients studied after initiation of a pathway.
Pathway: The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Before Group | Total | After Group |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 10 |
| ASA Level ASA I | 17 Participants | 29 Participants | 12 Participants |
| ASA Level ASA II | 51 Participants | 104 Participants | 53 Participants |
| ASA Level ASA III | 2 Participants | 7 Participants | 5 Participants |
| BMI | 27.8 kg/m^2 STANDARD_DEVIATION 5.1 | 28.0 kg/m^2 STANDARD_DEVIATION 4.7 | 28.2 kg/m^2 STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 135 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Procedure Time | 47 minutes STANDARD_DEVIATION 16 | 52 minutes STANDARD_DEVIATION 18 | 57 minutes STANDARD_DEVIATION 18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 62 Participants | 121 Participants | 59 Participants |
| Region of Enrollment United States | 70 participants | 140 participants | 70 participants |
| Rotator Cuff Repair Performed | 59 Participants | 123 Participants | 64 Participants |
| Sex: Female, Male Female | 28 Participants | 60 Participants | 32 Participants |
| Sex: Female, Male Male | 42 Participants | 80 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Primary Outcome - Worst NRS With Movement
worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.
Time frame: 0-48 hours after block placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Group | Primary Outcome - Worst NRS With Movement | Post-Op Day 1 | 5.6 score on a scale | Standard Deviation 3 |
| Before Group | Primary Outcome - Worst NRS With Movement | Post-Op Day 2 | 6.1 score on a scale | Standard Deviation 2.7 |
| After Group | Primary Outcome - Worst NRS With Movement | Post-Op Day 1 | 3.3 score on a scale | Standard Deviation 3.1 |
| After Group | Primary Outcome - Worst NRS With Movement | Post-Op Day 2 | 6.4 score on a scale | Standard Deviation 2.5 |
Secondary
Block Duration
Measures the duration of the block from: the time the block started to the time the block completely wore off the time the block started to the time the patient first noticed pain the time the block started to the time the patient felt normal sensation
Time frame: Through Post Op Day 2
Population: Some patients were lost to follow up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Before Group | Block Duration | Time to first notice pain | 21.1 hours |
| Before Group | Block Duration | Time to block start to wear off | 20.1 hours |
| Before Group | Block Duration | Time to block to completely wear off | 22.7 hours |
| Before Group | Block Duration | Time to normal sensation | 22.8 hours |
| After Group | Block Duration | Time to normal sensation | 28.6 hours |
| After Group | Block Duration | Time to first notice pain | 25.4 hours |
| After Group | Block Duration | Time to block to completely wear off | 28.4 hours |
| After Group | Block Duration | Time to block start to wear off | 23.2 hours |
Secondary
Pain Score at Rest
a NRS score on a scale from 0 to 10. 0 means no pain and 10 is the worst pain imaginable. A lower score is a better outcome.
Time frame: Post Op Days 1,2,7,14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Group | Pain Score at Rest | Post-Op Day 1 | 4.0 score on a scale of | Standard Deviation 2.9 |
| Before Group | Pain Score at Rest | Post-Op Day 2 | 4.2 score on a scale of | Standard Deviation 2.1 |
| Before Group | Pain Score at Rest | Post-Op Day 7 | 2.3 score on a scale of | Standard Deviation 2.1 |
| Before Group | Pain Score at Rest | Post-Op Day 14 | 2.2 score on a scale of | Standard Deviation 1.9 |
| After Group | Pain Score at Rest | Post-Op Day 14 | 1.7 score on a scale of | Standard Deviation 1.4 |
| After Group | Pain Score at Rest | Post-Op Day 1 | 1.9 score on a scale of | Standard Deviation 2.3 |
| After Group | Pain Score at Rest | Post-Op Day 7 | 3 score on a scale of | Standard Deviation 2.4 |
| After Group | Pain Score at Rest | Post-Op Day 2 | 4.7 score on a scale of | Standard Deviation 2.8 |
Secondary
Patient Satisfaction With Pain Management
Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome.
Time frame: Post Op Days 1,2,7,14
Population: Some patients were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Group | Patient Satisfaction With Pain Management | POD1 | 8.2 score on a scale | Standard Deviation 2.5 |
| Before Group | Patient Satisfaction With Pain Management | POD7 | 8.7 score on a scale | Standard Deviation 1.5 |
| Before Group | Patient Satisfaction With Pain Management | POD2 | 8.6 score on a scale | Standard Deviation 1.6 |
| Before Group | Patient Satisfaction With Pain Management | POD14 | 9 score on a scale | Standard Deviation 1.3 |
| Before Group | Patient Satisfaction With Pain Management | POD0 | 9.6 score on a scale | Standard Deviation 1.4 |
| After Group | Patient Satisfaction With Pain Management | POD14 | 9.1 score on a scale | Standard Deviation 1.7 |
| After Group | Patient Satisfaction With Pain Management | POD0 | 9.5 score on a scale | Standard Deviation 1.6 |
| After Group | Patient Satisfaction With Pain Management | POD1 | 9.2 score on a scale | Standard Deviation 1.7 |
| After Group | Patient Satisfaction With Pain Management | POD2 | 8.8 score on a scale | Standard Deviation 1.8 |
| After Group | Patient Satisfaction With Pain Management | POD7 | 9.1 score on a scale | Standard Deviation 1.7 |
Secondary
Total Opioid Use
The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated.
Time frame: Post Op Days 1,2,7,14
Population: some patients were lost to follow up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Before Group | Total Opioid Use | 0-24 hours | 15 morphine equivalent units (mg) |
| Before Group | Total Opioid Use | 24-48 hours | 22.5 morphine equivalent units (mg) |
| Before Group | Total Opioid Use | POD7 | 0 morphine equivalent units (mg) |
| Before Group | Total Opioid Use | POD14 | 0 morphine equivalent units (mg) |
| After Group | Total Opioid Use | POD14 | 0 morphine equivalent units (mg) |
| After Group | Total Opioid Use | 0-24 hours | 0 morphine equivalent units (mg) |
| After Group | Total Opioid Use | POD7 | 0 morphine equivalent units (mg) |
| After Group | Total Opioid Use | 24-48 hours | 15 morphine equivalent units (mg) |